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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Aligned Medical AMS16835 Fluids Kits are being recalled because they include Lidocaine Hydrochloride Injection, USP that was recalled by a supplier for quality issues.
Philips Azurion 7B12/12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
The BD Pyxis MedStation ES medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
Sharpoint 2.2 mm angled double-bevel microsurgical knives are being recalled because 3.0 mm knives were labeled and packaged as 2.2 mm. 1,818 units affected.
Philips Azurion 3M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
The BD Pyxis MedBank Tower medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
Philips Azurion 7M12 systems with the Roadmap Pro software key are being recalled because a pedal tap may cause a dark, clinically unusable image on the next fluoroscopy run.
Digital angiography and radiography systems are being recalled because contactors in the high voltage generator may weld together, leaving the power supply energized when the system is off.
The BD Pyxis MedStation 4000 medication cabinet is being recalled because the fingerprint scanner may overheat to a temperature capable of causing a first degree burn.
B. Braun CESK Northside Anesthesia Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
B. Braun SESK UPMC Double Catheter Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
B. Braun CESK Shands Jacksonville kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.
HiRes Ultra 3D CI HiFocus Mid Scala cochlear implants are being recalled due to an incorrect shelf-life expiration date. 36 units are affected.
B. Braun CESK Harris Methodist kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
B. Braun NES1725KFXL spinal epidural closed tip catheters are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack. 1,730 units affected.
B. Braun Lyndon B Johnson Hospital spinal epidural kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.
Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 units are affected.
Philips Medical Systems is recalling 27 Philips Azurion 3M15 units because a software issue can cause unusable dark images during imaging procedures.
Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.
B. Braun BlockJocks Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable. 210 units are affected.
Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.
B. Braun CESK Riverside Health System kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
DeRoyal Industries Inc. is recalling Covaderm Plus Vascular Access Dressings because they lack sterility assurance.
Medline Industries, LP is recalling Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection due to microbiology testing data integrity concerns and efficacy complaints.
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